Atossa Therapeutics Inc Stock Price, News & Analysis

Atossa Therapeutics (Nasdaq: ATOS) has received approval from the Swedish Ethics Review Authority to initiate a Phase 2 clinical trial of oral Endoxifen aimed at reducing mammographic breast density (MBD). MBD affects over 10 million women in the U.S. and can complicate cancer detection. The trial, named Karisma-Endoxifen, will enroll around 240 healthy premenopausal women for a six-month study period. The primary goal is to evaluate the dose-response relationship of daily Endoxifen on MBD, with secondary objectives assessing safety and tolerability.

Atossa Therapeutics, Inc. (Nasdaq: ATOS) reported financial results for Q2 2021, ending June 30, with cash balances of $142.4 million. The company achieved significant outcomes in its Phase 2 clinical studies, notably a 65.1% reduction in Ki-67 levels in breast cancer patients. Regulatory approvals from Sweden and Australia allow for the initiation of further clinical studies of Endoxifen and AT-H201. However, operating expenses surged by 78% and R&D costs rose by 130% compared to the previous year, reflecting increased clinical trial activities.

Atossa Therapeutics, Inc. (Nasdaq: ATOS) announces participation in the BTIG Virtual Biotechnology Conference on August 9-10, 2021. Steven Quay, President and CEO, and Kyle Guse, CFO, will engage in a fireside chat scheduled for August 9 at 10:00 a.m. ET. This event will be available for live streaming on the conference website, and a recording will follow. Investors are invited to schedule one-on-one meetings with the executives during the conference.

Atossa focuses on developing innovative treatments for unmet medical needs in oncology and infectious diseases, with emphasis on breast cancer and COVID-19.

On July 26, 2021, Steven Quay and international scientists released a pre-print paper examining the RNA sequencing data of early COVID-19 patients, suggesting severe contamination at the Wuhan Institute of Virology. Findings indicate that specimens from December 2019 contained significant levels of an undisclosed H7N9 influenza vaccine, over six times the amount of SARS-CoV-2. Additionally, Nipah virus gene sequences were identified, raising concerns about genetic manipulation. This contamination is problematic, given the lethal nature of the pathogens involved.

An international team of scientists, led by Dr. Steven Quay, has published a paper suggesting that a laboratory-acquired infection could be a more likely origin of COVID-19 than natural zoonotic transmission. The paper, presented to the US Congress, highlights insufficient biosafety levels in Wuhan labs and the absence of animal-to-human transmission evidence. Dr. Quay advocates for treating the lab leak theory as the primary hypothesis until new evidence emerges. Quay, a prominent figure in medicine, has contributed significantly to pharmaceuticals and pandemic survival strategies.

Atossa Therapeutics (Nasdaq: ATOS) has received regulatory approval from the HREC to initiate a clinical study of its nebulized formulation AT-H201 in Australia. This therapy aims to assist both moderately to severely ill COVID-19 patients and long-haul patients suffering from post-infection pulmonary issues. The Phase 1/2a study will evaluate 60 participants and aims to determine the efficacy of AT-H201, which has shown promising potency in in vitro tests against SARS-CoV-2. Successful trial results and regulatory approvals are essential for commercialization.

Atossa Therapeutics (Nasdaq: ATOS) announced its inclusion in the Russell 2000 and Russell 3000 Indexes, effective June 28, 2021. This event follows the announcement of preliminary additions on June 4 and June 14, 2021. CFO Kyle Guse highlighted this milestone as an opportunity to enhance investor awareness and liquidity. Membership in these indexes is determined by market-capitalization rankings and provides automatic inclusion in growth and value style indexes, impacting approximately $10.6 trillion in assets benchmarked against Russell's U.S. Indexes.

Atossa Therapeutics, Inc. (Nasdaq: ATOS) has received approval from the Swedish Medical Product Agency to launch a Phase 2 clinical trial of its oral Endoxifen aimed at reducing mammographic breast density (MBD), a significant public health concern affecting millions of women. The study will involve about 240 pre-menopausal women and aims to assess the dose-response relationship of Endoxifen over six months. The company plans to initiate the trial once COVID-19 restrictions in Stockholm are lifted, with potential for broader future studies to evaluate Endoxifen's impact on breast cancer incidence.

Atossa Therapeutics (Nasdaq:ATOS) reported final results from its Phase 2 study of oral Endoxifen for breast cancer. The primary endpoint was met, showing a 65.1% reduction in tumor cell activity, measured by Ki-67, dropping from 25.6% to 6%. All patients achieved a Ki-67 level below 25%, which correlates with improved long-term survival. Secondary endpoints confirmed Endoxifen's safety and tolerability, with no severe adverse events. Atossa plans to advance Endoxifen toward FDA approval, targeting the unmet need for effective treatments for ER+ breast cancer.